Pharmaceutical spending comes under scrutiny. With a letter dated 4 February 2026, the Minister of Health Orazio Schillaci asked AIFA for urgent clarifications on the trend of costs in the two-year period 2024-2025, reporting critical issues that have already generated tensions between the Agency and the Regions. With a formal but decisive tone, from the Lungotevere Ripa office came the request for greater transparency on the data and the development of a plan to prevent pharmaceutical spending from becoming a structural problem for the accounts of the National Health Service.
The letter refers to the data of OsMed Report 2024 and the most recent communications from the AIFA Board of Directors of January 2026. The picture described by the documents is that of growing pressure on the accounts, in an already complex context, characterized by two dynamics that cannot be underestimated:
- the aging of the population which increases the demand for care;
- the arrival on the market of high-cost innovative drugs.
The requests of the Ministry of Health to AIFA
The letter speaks openly of interpretative differences between AIFA and the Regions on the sustainability of spending and underlines how the internal controversies have affected the overall credibility of national health governance.
The Ministry is now asking for complete methodological documentation on the criteria with which pharmaceutical spending is evaluated, with a focus on the composition of costs and the authorization procedures adopted
Particular attention is also requested on the evidence of evaluation of health technologies (health technology assessment) who supported each choice and the expected benefits in clinical and economic terms. The crux is the relationship between cost and value: how much new drugs weigh on public finances and what results are already visible among patients.
New bimonthly report
Among Orazio Schillaci’s most relevant requests is the introduction of a bimonthly report. Starting from April 30, AIFA will have to provide a detailed analysis of spending trends, identify critical issues and indicate measurable actions to reduce it, accompanied by a roadmap and monitoring indicators.
Furthermore, any significant variation must be promptly communicated to the Ministry, also to stop divergences between institutions and bodies in the bud.
How much is the cost of medicines in Italy?
Pharmaceutical spending is one of the most delicate chapters of the healthcare budget. When it exceeds the programmed limits, the system must compensate elsewhere or intervene with corrective measures. But is the situation really as serious as it seems from Orazio Schillaci’s photograph?
The most up-to-date numbers available come from Monitoring of national and regional pharmaceutical spending January-September 2025presented to the AIFA Board of Directors last month.
In the first nine months of 2025, overall spending on medicines, adding direct and affiliated purchases, reached 18 billion and 420 million euros, with a deviation from the planned ceiling of 2.85 billion.
The statements of the president of AIFA
As stated by Robert Nisticò, president of AIFA, on the sidelines of the presentation of the report:
To ensure better governance of spending, the Agency is (…) developing an escape clause to manage access to reimbursement for new high-cost and innovative medicines.
Why do we spend so much on medicines
Pierluigi Russo, technical scientific director, explained that:
The trend of public pharmaceutical spending is influenced by multiple factors, including the introduction of innovative drugs and the aging of the population, which in Italy has shown a growing spending trend over the last 20 years, similar to that recorded in other developed countries with a public healthcare system.
He then highlighted that:
The growth in spending on direct purchases of drugs of each reimbursement class by public healthcare facilities was +4.9% currently (September 2025) while it was +9.1% in September 2024 and +15% in April 2024. In 2025 we will record a significant reduction in spending on innovative drugs following the expiry of the 36-month innovation license, required by law, transferring the burden to the purchase ceiling direct, which has been spending more than 10 years above the planned levels.
